Cooling system for localized and non-invasive cooling treatment

ABSTRACT

The cooling system ( 100, 300, 400, 500, 700, 750 ) includes an applicator ( 101, 501, 701 ) configured to hold a predetermined amount of solid coolant and fluid coolant ( 117 ) to cool a targeted area of the body ( 162, 570 ) to crystalize the lipid-rich cells underneath the targeted area to reduce the fat cells. The applicator may include a thermoelectric cooler (TEC,  136, 704, 706 ) where the hot side is cooled by coolant held within the applicator. The cold side of the TEC may be thermally coupled to a cooling plate ( 138, 560 ) configured to cool a targeted area of the skin at a predetermined temperature range for a predetermined period of time. The cooling system may also be used to relieve localized pain at certain area of the body and/or utilized for cryotherapy.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present Application claims priority and is a 35 U.S.C. 371Application of PCT/US2015/049436, which was filed Sep. 10, 2015,entitled COOLING SYSTEM FOR LOCALIZED AND NON-INVASIVE COOLINGTREATMENT, which itself claims the benefit of U.S. ProvisionalApplication Ser. No. 62/050,653, filed Sep. 15, 2014, entitled CoolingSystem For a Targeted Fatty Tissue, the entire disclosures of both thePCT and Provisional Applications are incorporated herein by reference.

FIELD

This invention is directed a cooling system that cools a targetedlipid-rich cells; and in particular, to a cooling system that cools thetargeted lipid-rich cells at a predetermined range of temperatures for apredetermined period of time to crystallize the lipid-rich cells due tothe cooling effects.

BACKGROUND

Cryotherapy is a local or general use of low temperatures, generallyexposing the body to subzero (0° C.) temperatures, for health benefits.Cryotherapy has been used to decrease inflammation, increase cellularsurvival, decrease pain and spasms, and promote overall health. It isnot generally considered as a medical procedure, but a non-invasiveoption for people seeking relief from pain and faster recovery frominjuries. The application of extreme cold temperature has also been usedto destroy abnormal or diseased tissue. Cryotherapy has also been usedto treat a number of diseases and disorders, such as warts, moles, skintags, solar keratosis, and to treat inflammation due to gout.

Cryotherapy has also been used to cool targeted lipid-rich cells, suchas excess body fat, to crystallize the lipid-rich cells to reduce thefat cells. Once the targeted fat cells are crystallized, thecrystallized fat cells may die and the immune system of the bodynaturally eliminates the crystallized fat cells from the body. Thisresults in a localized reduction of fat in the treated area part of thebody such that the user can target the area where he or she wants toreduce the fat cell and look better. One of the advantages of thecooling method for removing fatty tissue is that it does not requiresurgery or significant recovery time. However, cooling methods such asthe methods described in U.S. Pat. No. 7,367,341, which is herebyincorporated by reference, and other cryotherapies require complicatedmachinery, such as a pump to circulate coolant fluid to the coolingapplicator to maintain the cooling temperature at a desired level.Having complicated machinery such as a pump and an electronic coolingcontrol system can add costs and complexity to the applicator such thatmany potential users may not be able to afford the cooling procedureand/or cryotherapy. As such, there is a need for a cooling system thatcan lower the temperature, such as below subzero (0° C.) temperatures,around a targeted area of the body for health benefits such ascrystallizing the targeted fat cells to reduce the fat cells in thetargeted area of body/skin, without the complicated pump to make thecooling control system simple to use and more affordable.

INVENTION SUMMARY

A cooling system is configured to be placed over a targeted area of theskin and cool the targeted area of the skin at a predetermined cooltemperature range for a predetermined period of time to crystalize aportion of the fat cells underneath the targeted area of the skin inorder to reduce the fat cells underneath the targeted area of the skin.The cooling system may also be applied over the targeted area of theskin to relieve pain and/or for cryotherapy. The cooling system includesan applicator configured to hold a predetermined amount of coolant. Theapplicator may include a thermoelectric cooler (TEC) having a hot sideand a cold side. The coolant can be poured into the container orcontained within the applicator. The coolant may be thermally couple tothe hot side of the TEC to draw the heat away from the hot side tocontrol the temperature of the cold side of the TEC. The hot side may bethermally coupled to a radiator to improve the efficiency of drawingheat away from the hot side. The cold side may be thermally coupled to acooling plate configured to cool a targeted area of the skin at apredetermined temperature range for a predetermined period of time.

One aspect of the invention is directed to a cooling system forextracting heat away from a targeted area of the body, the coolingsystem comprising: a thermoelectric cooler (TEC) having a first side anda second side; and an applicator configured to hold a predeterminedamount of coolant, the applicator housing the TEC so that when theapplicator is filled with the predetermined amount of the coolant thefirst side of the TEC is thermally coupled to the coolant, and theapplicator having a cooling side thermally coupled to the second side ofthe TEC and configured to extract heat away from the targeted area ofthe body.

Another aspect of the invention is directed to a cooling systemincluding an applicator having a thermoelectric cooler (TEC) with a hotside and a cold side, the applicator configured to hold coolantthermally coupled to the hot side of the TEC such that the cold side canlower the temperature of a targeted area of the skin at a predeterminedcool temperature range for a predetermined period of time, theapplicator having a sensor to detect whether the coolant is anauthorized coolant, the cooling system including: a predetermined amountof coolant including an antifreeze ingredient and an authenticationingredient to maintain the predetermined amount of coolant fluid below−5° C., and the authentication ingredient detectable by the senor todetermine if the predetermined amount of coolant is an authorizedcoolant.

Yet another aspect of the invention is directed to a method of cooling atargeted area of the skin, the method comprising: chilling apredetermined amount of coolant; holding the predetermined amount ofcoolant within an applicator having at least one thermoelectric cooler(TEC) having a hot side and a cold side; placing the applicator over thetargeted area of the skin; conducting heat away from the hot side to thepredetermined amount of coolant held within the applicator; andcontrolling the temperature of the cold side of the TEC to cool thetargeted area of the skin within a predetermined range of cooltemperatures for a predetermined period time.

Still another aspect of the invention is directed to a cooling systemconfigured to cool a targeted area of the skin, the cooling systemincluding: a predetermined amount of coolant capable of being chilledbelow −5° C. and remain substantially fluid; an applicator having athermoelectric cooler (TEC) with a hot side and a cold side, theapplicator configured to receive the predetermined amount of coolantsuch that the hot side of the TEC is thermally coupled to thepredetermined amount of coolant and the cold side of the TEC configuredto cool the targeted area of the skin; and a power supply to providepower to the TEC to cool the cold side of the TEC.

Another aspect of the invention is directed to a method of cooling atargeted area of the skin with an applicator having a thermoelectriccooler (TEC) with a hot side and a cold side, the hot side thermallycoupled to a predetermined amount of coolant within the applicator tocool the hot side to maintain the cold side at a predetermined range oftemperatures for a predetermined period of time, the method comprising:measuring the temperature of the predetermined amount of coolant withinthe applicator; calculating a rate of temperature increase of thepredetermined amount of coolant; and adjusting the temperature of thecold side of the TEC to an upper temperature limit within thepredetermined range of temperatures if the rate of temperature increaseis too high so that the temperature of the cold side of the TEC iswithin the predetermined temperature range for the predetermined periodof time.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention can be better understood with reference to the followingdrawings and description. The components in the figures are notnecessarily to scale, emphasis instead being placed upon illustratingthe principles of the invention. Moreover, in the figures, likereferenced numerals designate corresponding parts throughout thedifferent views.

FIG. 1 shows a perspective of a cooling system.

FIG. 2 shows the applicator with the cover removed showing a firstportion of solid coolant and a second portion of fluid coolant.

FIG. 3 shows the applicator with the lid removed showing the interiorspace of the applicator.

FIG. 4 shows an underside of the applicator.

FIG. 5 shows a cross-sectional view of the applicator along the line 5-5shown in FIG. 1.

FIG. 6 shows a cross-sectional view of the applicator applied over atargeted area of the skin.

FIG. 7 shows a cross-sectional view of a torso with the applicatorapplied over the targeted area of the skin.

FIG. 8 shows a perspective view of a radiator.

FIG. 9 shows a perspective view of another radiator.

FIG. 10 shows a block diagram of a controller.

FIG. 11 shows an exemplary flow chart relating to the cooling procedure.

FIG. 12 shows an exemplary flow chart relating an authentication processof the coolant.

FIG. 13 shows an exemplary flow chart directed to monitoring thetemperature of the coolant.

FIG. 14 shows an exemplary flow chart generally directed totransitioning the user into the cooling procedure to mitigate thediscomfort due to the cold temperature.

FIG. 15 shows an exemplary flow chart directed to a cooling kit.

FIG. 16 shows a bottom view of an applicator having a base divided intotwo cooling pods.

FIG. 17 show that the base of the applicator divided into a plurality ofpods.

FIG. 18 shows a bottom view of the applicator with another podconfiguration.

FIG. 19 shows a perspective of another applicator having a chamberconfigured to draw the targeted area of the skin into the chamber.

FIG. 20 shows the applicator of FIG. 19 with the lid removed showing theinterior space of a container.

FIG. 21 shows the applicator including a pump to generate vacuumpressure within the chamber.

FIG. 22 show a bottom perspective view of the applicator showing thechamber underneath the base of the container.

FIG. 23 show a cross-sectional view of the applicator of FIG. 19 alongthe line 23.

FIG. 24 shows a cross-sectional view of the applicator of FIG. 19 alongthe line 24.

FIG. 25 shows an exemplary block diagram to operate the applicator ofFIG. 19.

FIG. 26 shows an exemplary flow chart directed to monitoring thetemperature of the coolant.

FIG. 27 shows an exemplary flow chart relating to the cooling procedureof the applicator illustrated in FIG. 19.

FIG. 28 shows another embodiment of a cooling system.

FIG. 29 shows a cross-sectional view of yet another cooling system.

FIG. 30 show a cross-sectional view of another cooling system.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a perspective of a cooling system 100 including anapplicator 101, a power supply 114, a pouch 117 fill with fluid coolant,and an antifreeze liner 160. The applicator 101 may have a container 102with a rim 104 adapted to couple to a lid 106. The lid 106 may have acover 108 adapted to release from the lid 106. For example, the cover108 may be rotated either clockwise or counter-clockwise direction totighten onto the lid or released from the cover 108, respectively. Asdiscussed in more details below, the applicator 101 may include athermoelectric cooler (not shown in FIG. 1, referred to as TEC) with ahot side and a cold side to cool a targeted area of the skin within apredetermined range of temperatures for a predetermined period of time.The applicator 101 may have a duct 110 to route the electrical cables112 from the TEC that terminates into a plug 113 that is adapted toelectrically couple to a power supply 114. The lid 106 may be coupled tothe container 102 in a variety of ways. For instance, the lid 106 may becoupled to the container 102 through nuts and bolts such that coolantinside the applicator may be substantially sealed therewithin such thatthe coolant does not leak. Alternatively, the lid 106 may be hinged tothe container 102 such that the lid may open and close along one edgesimilar to a lid on an ice box.

The cooling system 100 may include a pouch 117 with fluid coolantinside. As discussed in more detail below, the coolant may include anantifreeze ingredient that keep the coolant fluid below 0° C. or atlower temperatures such as −5° C., −10° C., and −15° C. In preparationfor the cooling procedure, the pouch may be placed inside a freezeruntil the temperature of the coolant inside the pouch 117 reach a steadystate temperature, such as more than 12 hours. With the cover 108opened, the coolant may be poured into the applicator 101 to cool thehot side of the TEC, and power to the TEC may be adjusted accordingly tocontrol the temperature of the cold side of the TEC within the desiredtemperature range to chill the fat cell underneath the targeted area ofthe skin. The cooling system 100 may also include the antifreeze liner160 which may be placed over the targeted area of the skin to protectthe skin from freeze damage. Once the liner 160 is placed over thetargeted area of the skin, the applicator may be placed over the liner160 for the cooling procedure.

FIG. 2 shows the applicator 101 with the cover 108 removed, whichexposes an opening 116 of the lid 106. With the cover 108 removed,coolant may be placed inside the applicator 101. The coolant may includea first portion of solid coolant and a second portion of fluid coolant.The first portion of the solid coolant may be ice cubes 119, which maybe first inserted into the container until the applicator issubstantially full of ice cubes. The second portion of the fluid coolant121 may be poured into the applicator to fill the gaps among the icecube 119 until the fluid coolant substantially fill the applicator 101.The fluid coolant 121 inside the pouch 117 may be chilled below −5° C.before being poured into the applicator 101. The container 102 may beformed from a flexible non-porous material such as rubber or any othermaterial known to one skilled in the art configured to hold coolanttherewithin and flexible to contour the shape of the targeted area ofthe body. The applicator may be configured to hold from 60 oz to 140 ozof coolant; and in particular, from 80 oz to 120 oz of coolant, and infurther particular about 100 oz of coolant. It should be noted, the sizeof the applicator is not limited to any particular volume range notedabove. Rather, the size of the applicator may be determined by thecooling application such that the applicator may be sized and configuredto hold sufficient amount of coolant to cool the targeted area of theskin within a predetermined range of temperatures for a predeterminedamount of time. In general, lower the required cooling temperature ofthe targeted area of the skin or a longer period of cooling procedure, alarger applicator 101 may be required to hold more coolant. In otherwords, more coolant may be needed to conduct the heat away from the hotside of the TEC so that the cold side of the TEC may be cooled to alower temperature or for a longer period of treatment time.

FIG. 3 shows the applicator 101 with the lid 106 removed showing theinterior space 118 of the container 102. The container 102 may have abase 120 with side walls 122 extending upward and forming the rim 104.The base 120 of the container 102 may form first and second pods 124 and126, and each pod may be adapted to couple to a thermoelectric coolingsystem 128 (TEC system). The TEC system 128 may include a radiator 130which may be cooled by the first portion of the solid coolant and thesecond portion of the fluid coolant within the container 102 asdiscussed in more detail below. The applicator 101 may also include atemperature sensor 123 to measure the temperature of the coolant insidethe container 102. The container 102 may also include sensors 125 tomeasure certain properties of the coolant such as its electricalconductivity, salt level, and etc. in order to identify the coolant asbeing an authorized coolant, if the coolant is within a certainparameter so that the coolant works properly with the applicator.

FIG. 4 shows an underside of the container 102 having the base 120 withthe first and second pods 124 and 126 protruding therefrom. The firstand second pods may have their respective cutouts 132 and 134, adaptedto receive a TEC (not shown) and a corresponding cooling plate (notshown) discussed in more detail below. The planer surfaces of the firstand second pods 124 and 126 may be at an obtuse angle “A” or be lessthan 180° relative to each other so that the two pods 124 and 126 maycontour the outer shape of the targeted area of the body to betterimprove the surface area contact between the cooling plates (not shown)and the targeted area of the skin.

FIG. 5 shows a cross-sectional view of the applicator 101 along the line5-5 shown in FIG. 1. The TEC system 128 may include a TEC 136 betweenthe radiator 130 and a cooling plate 138. The TEC 136 has anintermediate layer 140 between a first side 142 and a second side 144.The power to the TEC 136 may be provided such that the first side 142may be the hot side and the second side 144 may be the cold side. TheTEC 136 may utilize the Peltier effect where whenever direct currentpasses through the circuit of heterogeneous conductors, heat is eitherreleased or absorbed at the conductors' junctions, which depends on thecurrent polarity. The amount of heat may be proportional to the currentthat passes through conductors. When direct current moves across aPeltier device, it causes temperature differential between the first andsecond sides 142 and 144. As a result, the first side 142 may be hotwhile the opposite second side 144 may be cold or cooler relative to thefirst side 142, and vice versa if the polarity of direct current isreversed. In general, if the heat generated on the hot side iseffectively dissipated into heat sinks and further into the surroundingenvironment, then the temperature on the cold side may be much lowerthan that of the ambient by dozens of degrees. The TEC's coolingcapacity may be proportional to the current passing through theinterconnected layer 140.

The applicator 101 may also include one or more temperature sensors 150adapted to measure the temperature of the cooling plate 138 to estimatethe temperature of the targeted area of the skin of the user. Thetemperature along the cooling plate 138 may be maintained within apredetermined range of temperatures by adjusting the power supplied tothe TEC 136. For instance, if the temperature sensor 150 indicates thatthe temperature of the cooling plate 138 is below a predetermined lowerlimit cooling temperature, the power to the TEC 136 may be reduced orturned OFF such that the temperature of the second side 144 may rise,and vice versa. The radiators 130 may be thermally coupled to the firstside 142 of the TEC to dissipate the heat more efficiently using athermal paste for example. Conversely, if the temperature sensor 150indicates that the temperature of the cooling plate is above thepredetermined cooling upper limit temperature, then the power to the TECmay be increased or turned ON or the polarity of the voltage may bereversed so that the temperature of the second side 144 may be lowered.This way, the temperature of the treated area of the skin may besubstantially maintained within a predetermined range of temperatures.

The cooling plate 138 may be formed from a thermally conductive materialsuch as aluminum, copper, iron, stainless steel, and thermallyconductive plastic. The cooling plate 138 may have a first side 152 anda second side 154. The cooling plates may also be formed from 3Dprinting process to customize the shape of the cooling plate for surfaceareas of the body parts that have sharp bends such as chin and footareas. For instance, a cooling system with a customized cooling platefor user's chin may be used to remove fatty cells within the chin area.The base 156 of the radiator 130 may overlap the cutout 132 adapted tosubstantially seal the cutout 132 such that liquid and/or coolant may besubstantially prevented from leaking through the gaps between the TEC136 and the cutout 132. Thermal paste may be applied between the base156 and the first side 142 of the TEC 136, and between the second side144 of the TEC 136 and the first side 152 of the cooling plate toimprove the efficiency of conducting heat through the radiator 130, TEC136, and the cooling plate 138.

A gasket and/or sealant may be also applied between the base 120 of thecontainer 102 and the base 156 of the radiator to substantially preventliquid from leaking through the gap between the TEC 136 and the cutout132. The radiator 130 may have a plurality of fins 158 to improve theefficiency of dissipating heat away from the TEC 136. Couplers 161 (seeFIG. 3) such as rivets, screws, anchors, and the like may be used tocouple the radiator 130 and the cooling plate 138 together so that theradiator, TEC, and the cooling plate may substantially maintain thermalcontact with each other. The lid 106 may be releasably sealed to the rim104 of the container 102 to substantially prevent coolant within thecontainer from leaking and substantially preventing atmospheric air fromentering the container.

The internal space 118 of the container 102 may be sized to holdsufficient amount of the first portion of the solid coolant such as icecubes alone and/or in combination with the second portion of the fluidcoolant to substantially maintain the cooling plate 138 temperaturewithin a predetermined range of temperatures, such as from about −15° C.to about 10° C., and in more particularly from about −10° C. to about 0°C. or from about −6° C. to about −4° C. for about 20 minutes to about120 minutes, from about 60 minutes to about 120 minutes, and from about75 minutes to about 90 minutes. Each of the cooling plates 138 may havea temperature sensor 150 to monitor the temperature between the coolingplates and the targeted area of the skin to maintain the temperature ata predetermined range by controlling the voltage and/or current providedto the TEC 136.

FIG. 6 shows a cross-sectional view of the applicator 101 applied over atargeted area of the skin with a liner 160 between the cooling plates128 and the targeted area 162 of the skin. The current or power to thetwo TECs 136 may be provided by first and second wires 146 and 148,along with other wires for temperature sensors 150, not shown, which maybe combined to form the cable 112. The cable 112 may have a distal endforming the plug 113 adapted to electrically couple to the power supply114 to power the TECs 136. The liner 160 may be soaked with antifreezesolution to protect the targeted skin from freeze damage such as freezerburns. The two pods 124 and 126 may protrudes from the base 120 of thecontainer 102 and may be configured so that the adjacent cooling plates128 may have an obtuse angle to better contour the curvature shape ofthe user's abdomen, flanks, buttocks, back, chin, foot, inner and outerthighs, and the like. The cooling plates 128 may be shaped and size tocontour the smaller portions of the body such as lower face, submentum,and neck as well.

The cross-sectional view shows the targeted area of the skin 162including an epidermis layer 164, a dermis layer 166, and a subcutaneousadipose layer 168. In general, the epidermis layer may be also describedas the surface layer of the skin, and the subcutaneous layer 168 may bealso described as the fat cells. When a targeted area of the skin iscooled at a predetermined cool temperature range for a period of time, aportion of the subcutaneous layer (fat cells) may freeze or crystalize.In general, the fat cells may freeze at an elevated temperature comparedto its top epidermis and dermis layers such that the fat cellsunderneath the epidermis and dermis layers may crystalize or freezewithout damaging the epidermis and dermis layers.

FIG. 7 shows a cross-sectional view of a torso 170 with the applicator101 applied over the targeted area 162 of the skin with the liner 160between the applicator 101 and the skin. A strap 172 may wrap around thetorso or waist 170 to apply pressure on the applicator 101 to ensuresurface area contact between the cooling plates 128 and the targetedarea of the skin. The strap 172 may be elastic to provide some tensionto apply constant pressure on the applicator 101. The pressure on theskin by the applicator may improve the efficiency of cooling the threelayers 164, 166, and 168. The strap may be adjustable and elastic to fitdifferent body types. The container 102 may be made of flexible materialsuch that the container 102 may bulge out when pressed on by the strap172 to allow the cooling plates 128 to better conform to the outer bodycontour shape of the torso 170 of the user. This may allow theapplicator to conduct heat away from the three layers 164, 166, and 168more efficiently to shorten the amount of time it takes to cool the fatcells. Alternatively, a number of other clamping mechanisms, belts, andan inflatable cuff known to one skilled in the art may be used to strapthe applicator onto the targeted area of the skin.

FIG. 8 shows a perspective view of the radiator 130 having a width W, adepth D, a height H, and a plurality of fins 174 with a height FH. Thebase 156 of the radiator 130 may have holes 176 adapted to receive thecouplers 161 to couple the radiator to the cooling plates 138. In thetesting the cooling system 100 as discussed below, radiators made ofaluminum extrusion with the following dimensions were used: W≈2.5″ (63.5mm), D≈2.5″ (63.5 mm), H≈0.14″ (3.5 mm), and with nine (9) fins havingFH≈0.43″ (11.0 mm). It is within the scope of this invention to use aradiator with alternative W, D, H, and FH dimensions to dissipate thedesired amount of heat from the hot side of the TEC. Moreover, thenumber of fins 174 used in the radiator may be adjusted to dissipateless or more heat from the TEC depending on the application. Forinstance, FIG. 9 shows a radiator 178 with seven (7) fins instead of thenine (9) fins utilized in the radiator 130. With less fins, less heatmay be dissipated away from the hot side of the TEC such that thecoolant within the container 102 may remain cooler for a longer periodof time versus the radiator with nine fins. On the other hand, the coldside of the TEC may not get as cold with the seven fins compared to ninefins. Alternatively, utilizing a more thermally conductive material forthe radiator such as cooper may also improve the efficiency of radiatingheat away from the hot side of the TEC.

FIG. 10 shows a controller block diagram 180 adapted to operate theapplicator 101. The controller 180 may include a processor 182communicably coupled to the power supply 114, a memory 184, one or moreTECs 136, and the corresponding temperature sensors 150 to measure thetemperature of the corresponding TECs 136, the temperature sensor 123 tomeasure the temperature of the coolant, and the sensor 125 to measurethe coolant to determine if the coolant is an authenticate coolant ornot. The processor 182 may be also communicably coupled to a counter 185configured to keep track of number of times the applicator 101 has beenused. The processor 182 may control the power supply 114 to providepower to the TECs 136 through the wire 146.

Testing Sample Applicator:

For testing purposes, an applicator similar to the drawing shown inFIGS. 1 and 2, was constructed with a flexible container configured tohold about 104 oz of coolant. Two TEC1-12712 rated at 12V and 12 ampeach were used with a square dimension of 40 mm (width)×40 mm(height)×3.2 mm (depth). The hot side of each of the TEC1 was thermallycoupled to the radiator 130, generally described in FIG. 8, having W ofabout 2.5″ (63.5 mm), D of about 2.5″ (63.5 mm) with nine (9) finshaving a height of about 11.0 mm. The cold side of each of the TEC wasthermally coupled to the cooling plate having a rectangular dimensionsof about 3.9″ (100 mm)×about 3.15″ (80 mm). Both the radiators 130 andthe cooling plates 138 are made of aluminum material. Thermal paste wereused to ensure good thermal conductivity amongst the radiator 130,TEC1s, and the cooling plate 138. The width of the cooling plates andthe radiators are both wider than the square opening to substantiallyseal around the square opening. Screws were used to couple the radiatorsand the cooling plates together to ensure that the radiator and thecooling plate remained in good thermal contact. The two wires 146 and148 from the two TECs and the wires for the temperature sensors wererouted to form the cables 112. Sealant was applied over the screws, andbetween the radiator 130 and the base 120 of the container, and betweenthe cooling plates 138 and the underside of the base 120 tosubstantially prevent the coolant from leaking from the container.

FIG. 11 shows a flow chart 186 related to the cooling procedure. In step188, in reference to FIG. 2, in preparation for the cooling procedure,the pouch 117 filled with coolant may be inserted into a freezer forseveral hours before the procedure to allow the coolant inside the pouchto cool below 0° C. (32° F.). The coolant may include antifreezeadditive which lowers the freezing point of water-based liquid. Avariety of antifreeze additive may be added to liquid such as water tolower the freezing point. For example, antifreeze additive may includeone or more of the following solutions, such as, ethyl alcohol,isopropyl alcohol, methanol ethylene glycol, propylene glycol, andglycerol. For instance, from about 5% to about 50% by volume of 70%proof isopropyl alcohol may be mixed with water to form the secondportion of the fluid coolant that is fluid below 0° C. so that thecoolant may be poured into the container such that the coolant fills thegap between the ice cubes. A number of different mixture combination ofantifreeze and water may be formed to formulate the fluid coolant sothat the coolant remains fluid below −15° C. or below −20° C. so thatthe mixture of the first portion of the solid coolant such as ice cubesand the second portion of the fluid coolant inside the container isbelow 0° C., or below −10° C., or below −15° C. such that the mixturesubstantially remains cool below about 15° C. after the procedure isdone.

In step 190, the first portion of the solid coolant was inserted intothe applicator. In the test, about 1,376 grams of ice cubes wereinserted into the container 102. Note that with the cover opened, theapplicator 101 can hold about 104 oz of water. In step 192, the secondportion of the fluid coolant was poured into the applicator. In thistest, the applicator 102 was filled with about 1,414 grams of fluidcoolant. The fluid coolant used in this test was formulated by using ablender to crush about 1018 grams of ice cubes with about 400 grams ofchilled rubbing alcohol in a bottle. In preparation for this test, abottle of rubbing alcohol containing about 70% proof isopropyl alcoholwas placed inside a freezer for more than 24 hours before the test wasconducted. The chilled rubbing alcohol was still liquid and the measuredtemperature was about −11° C. The combination of ice cubes and chilledrubbing alcohol in the amount noted above were crushed using a householdblender until the mixture was slushy yet fluid so that the coolant couldbe readily poured into the applicator. After the blending was over, thecoolant measured about −17° C. Even at this low temperature (−17° C.),the coolant was still fluid so it poured into the container through theopening with minimal clogging. The measured temperature of the ice cubesand the fluid coolant inside the applicator was about −15° C. After thecontainer was filled with ice cubes and fluid coolant, the cover 108 wasplaced over the opening 116. As such, a total of about 2,790 grams ofice cubes and fluid coolant, which is total of about 98.4 oz were pouredinto the applicator having a capacity of about 104 oz. On a side note,blending ice with chill water at about 0° C. without the antifreezeusing a blender may make the coolant slushy but the coolant may clungtogether such that it may be bit troublesome to pour the slushy coolantinto the opening of the lid. Note that blending ice cubes with chilledwater, however, is within the scope of this invention.

In step 194, a protective liner was placed over the targeted area, whichwas the upper abdomen. The protective liner was 42 cm×34 cm rectangularshape, which was soaked with antifreeze additive to protect the skinfrom freezer burn. In step 196, the applicator was placed over thetargeted area. A thermocouple was placed between the cooling plate andthe protective liner to measure the temperature of the cooling plate.

In step 198, the applicator was secured over the targeted area of theskin using an elastic strap wrapped around the upper abdomen around thetorso. The strap substantially ensured that the applicator did not movearound relative to the targeted area of the skin. The initial surfacetemperature of the skin was about 32° C. With the coolant temperatureinside the container being less than −15° C., the temperature of thecooling plates dropped even without any power to the TECs.

In step 200, power was provided to the TECs to cool the targeted area ofthe skin. Power can be provided by connecting the electrically cables toa PWM power supply to supply DC current to the two TECs. The powersupply was then turned ON and OFF several times to further lower thetemperature of the cooling plates within a temperature range of between0° C. and −4° C. In other words, the power supply was turned ON when thetemperature rose to 0° C. and it was turn OFF again when the temperaturedropped to −4° C., and vice versa. At about 60 minutes into theprocedure, most of the ice in the container had melted, which mayindicate that the temperature of the coolant has warmed up from theinitial temperature of about −15° C. to about 0° C. The test continuedin this manner for another 15 minutes for a total of about 75 minutes.During the last 15 minutes, as the temperature of the coolant in thecontainer rose, the power supply was mostly ON, and the applicator wasable to maintain the temperature of the cooling plates from about 0° C.to about −2° C.

In general, it has been observed that colder the coolant temperature,the TEC may cool the cooling plates to a lower temperature. Moreover,colder coolant temperature allows for a longer period of coolingtreatment procedure. As such, the power to the power supply may beturned ON and OFF more frequently initially when the coolant temperatureis cooler, such as below −10° C., as the radiator can quickly dissipatethe heat from the TEC at a lower temperature. Conversely, as the coolanttemperature rises, the power to the TEC may be turned ON and OFF lessfrequently to maintain the desired cooling plate temperature. And oncemost, if not all, of the ice cubes in the container melted, the power tothe TEC may be turned ON continuously. As such, the fluid coolant may beprovided in a variety of different mixtures depending on the coolingtreatment application. For instance, for shorter cooling treatments, thefluid coolant may be chilled water near the freezing point; and thefluid coolant may also be a blend of crushed ice with chilled water. Forlonger cooling treatment cycle or if colder cooling plate temperature isrequired, the fluid coolant may be a blend of crushed ice withanti-freezing liquid or any combination thereof. Alternatively, thepredetermined amount of coolant may be entirely of fluid coolant formedfrom a blend of crushed ice cubes and antifreeze ingredient. As such,the percentage by mass between the solid coolant and fluid coolant mayvary depending on the application. For instance, 0% by mass of solidcoolant and 100% by mass of fluid coolant is within the scope of theinvention, as well as 100% by mass of solid coolant and 0% by mass offluid coolant, and any combination of ratio between these two extremeratios.

Note that a variety of factors may affect the performance of theapplicator such as the efficiency of the thermal materials used for theradiators and the cooling plates, using copper material versus aluminum,along with the construction of the radiators such as a number of fins,and the efficiency of the thermal contacts among the radiator, TEC, andthe cooling plate. A variety of other factors can affect the temperaturedifferential between the coolant and the cooling plates, such as theroom temperature, the area of the body the applicator is being used, thebody fat content, and etc. As such, the temperature ranges discussedabove in regards to the applicator for the testing purpose should not betaken as limiting the scope of this invention in anyway. Rather, thetemperature ranges discussed relating to this test should be regarded asa general performance of this particular applicator constructed for thistest. As such, the test described here should be considered as anexemplary temperature ranges that may be possible when the coolingprocedure is conducted in a manner described above and the testingresults may vary.

In step 202, once the cooling procedure is done, the applicator wasremoved from the targeted area of the skin. Shortly thereafter theapplicator was removed, the temperature of the coolant was measured, andit was about 15° C. In addition, the targeted area of the skin wasexamined, and it was noticed that some portion of the targeted area ofthe skin was red and somewhat hardened indicating that some portion ofthe subcutaneous fat layer may have harden or frozen.

In step 204, the targeted area of the skin was massaged to soften thehardened area of skin. It may take up to about 5 minutes of massagingfor the hardened area of the skin to soften. The massaging of the hardenarea of the skin may separate the crystalized fat cells fromnon-crystalized fat cells to allow the natural immune system to removethe crystalized fat cells more effectively, and this may allow thetargeted area of the skin to reduce the fat cells more evenly. Thetargeted area of the skin remained red for about 5 hours and it returnedto its natural color after about 8 hours.

FIG. 12 shows a flow chart 206, which may be a subset of the step 194 ofthe flow chart 180. The flow chart 206 is directed to detecting whetheran authorized coolant is used with the applicator 101. In step 208, thesensor 125 may measure the properties of the coolant poured into thecontainer. In step 210, the processor may compare the measuredproperties of the coolant versus one or more specified properties thecoolant should have stored in the memory 204. The specified propertiesof the coolant may be a variety of one or more factors such aselectrical conductivity of the coolant and/or the salt level. Forinstance, the coolant in the pouch 117 may include a predeterminedpercentage by mass of sodium compared to the liquid such as water toincrease the electrical conductivity of the coolant. The sensor 125 maymeasure the electrical conductivity of the coolant or any otherparameters such as to determine if the coolant is an authorized coolantfor not. The processor 202 may compare the measured coolant propertywith the predetermined property of the coolant stored in the memory. Ifthe measured coolant property does not match the predetermined propertyof the coolant, then the processor may stop the cooling procedure. Onthe other hand, if the measure coolant property does match thepredetermined property of the coolant, then the processor 202 mayproceed with the cooling procedure 212. A variety of other detectionmethods known to one skilled in the art may be used for theauthenticating purposes.

FIG. 13 shows a flow chart 220 directed to monitoring the temperature ofthe coolant to cool the cooling plates within a predetermined range ofcooling temperature for a predetermined period of time. In step 222, theprocessor 202 may provide power to the TECs 136 to maintain thetemperature at the cooling plates within a predetermined rang of lowerand upper temperature range. In step 224, the temperature of the coolantmay be measured using the temperature sensor 123. In step 226, theprocessor 202 may then store the measured coolant temperature and thetime the measurement was made during the cooling procedure into thememory 204. The processor may then calculate the rate of temperaturechange in the coolant based on the difference in temperature of thecoolant over the time difference, which may be represented as dTc/dt. Instep 228, the processor may determine based on dTc/dt, whether thecoolant will be cold enough to maintain the cooling plates 128 withinthe desired range of the lower and upper temperatures for a desiredperiod of time. For instance, depending on the cooling application, thedesired time may be between 30 and 120 minutes such as at least 30minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, and 120minutes. In step 230, if the desired time for the cooling procedure haspassed, then the processor 202 may go to the stop command 232. On theother hand, in step 234, if the desired time has not passed, then theprocessor 202 may determine if the rate of temperature change in thecoolant is faster than the desired rate such that the coolant may not becold enough to maintain the cooling plate at the desired temperature forthe desired period of time. In step 236, if the rate of temperaturechange is too fast, then the processor may adjust the desiredtemperature to the higher temperature such as maintaining the averagetemperature to be about −4° C. instead of about −6° C. On the otherhand, in step 238, if the rate of temperature change is slower than thedesired rate, then the processor may maintain current averagetemperature of the cooling plates.

FIG. 14 shows a flow chart 240 with further details of step 222 of flowchart 220 of FIG. 13 generally directed to transitioning the user intothe cooling procedure to mitigate the discomfort due to the coldtemperature from the cooling plates. In step 242, the processor maydetermine if the cooling procedure is within an initial stage. In step244, if the cooling procedure is within the initial stage, then theprocessor my cool the cooling plates to the initial temperature setting,which may be higher than the normal cooling temperature. This may easethe user into the normal cooling temperature to minimize the discomfortfrom the cold temperature from the cooling plates. For instance, theinitial stage may be from the first 5 minutes to about the first 10minutes of the procedure; and within this initial stage, the processormay set the initial temperature range from about 0° C. to about −4° C.,and in particular from 0° C. to about −2° C., which may be higher thanthe normal cooling temperature.

In step 246, after the initial stage, the flow chart 240 may include asecond stage to further transition the user into the cooling treatment.For instance, the second stage may be between about 5 minutes to about10 minutes into the procedure; and in step 248, within this secondstage, the processor may set the second temperature range that isbetween the initial stage and the final treatment temperature settingsuch as from about −2° C. to about −4° C.

In step 250, after the initial and second stages, the processor maydetermine if the treatment is in the final stage. In step 252, if thetreatment is in the final stage, the processor may set the finaltreatment temperature for the remaining time period until the procedureis finished. For instance, the final treatment temperature range may beset from about −4° C. to about −6° C. After these steps are done, theflow chart 270 may go back to step 224.

FIG. 15 shows a flow chart 270 directed to providing a cooling system260 to a user. In step 272, an order may be received from a user with adesired number of treatments. In general, the targeted area of the skinmay need to be treated more than once to notice a meaningful fatreduction. For example, two or more cooling treatments may be needed inthe same targeted area of the skin with the applicator 101 to notice thefat reduction in the targeted area of the skin. Moreover, a variety ofdifferent areas of the body may be treated with the applicator 101 suchas abdomen, flanks, buttocks, back, inner and outer thighs, and thelike. As such, a number treatments the user may order may vary dependingon the user.

In step 274, the counter 205 for the applicator 101 may be set to thedesired number of treatments as requested by the user in step 272 for adesired amount of time. For instance, if each treatment time is about 90minutes, the counter 185 may reduce the number of treatment available byone after each 90 minute treatment cycle, and let the user know thenumber of treatment(s) which is/are left. In addition, the counter 185may be set to allow the user to rent the cooling system for a sufficientperiod of time to allow the user to perform all the ordered treatments.In step 276, a cooling system or cooling kit may be assembled includingthe applicator 101, with a predetermined number of liners and coolantsequal to the desired number of treatments ordered by the user. Thecooling system may also be comprised of just the liner and the coolant.Each treatment cycle may require the use of one liner and one pouch 117filled with coolant. As such, if the user orders ten (10) treatments,the cooling system may include an applicator with the counter set at ten(10) treatments, ten (10) liners, and ten (10) coolant pouches.

In step 278, the cooling system may be shipped to the user for apredetermined amount of time to allow the user sufficient time tocomplete the number of treatments the user ordered. For instance, if theuser orders ten (10) treatments in reference to step 272, it may take upto two months to perform the ten treatments at home. As such, thecounter 185 may be set to operate ten treatments, and to stop workingafter a predetermined number of dates such as 60 days from the coolingsystem is shipped to the user. As such, the applicator may stop workingafter the desired number of treatments have been performed and/or afterthe predetermined number of dates have passed. In general, the user mayneed to wait about 2 to 4 weeks between two subsequent treatments toallow the targeted area of the skin to recover from the prior coolingtreatment. For instance, the user may need about one or several monthsto treat one or more targeted areas several times such that the user mayrent the applicator for the desired amount of time. Note that it iswithin the scope of this invention to remotely reset the counter withregard to the number of treatments and the number of days the applicatormay operate in the event that the applicator malfunctions such that thecounter needs to reset while the applicator is in user's possession.

In step 280, once the user is finished with the number of treatments theuser ordered or the allotted time for the applicator has expired, theuser may order more treatment or extend the time allotted for thetreatments ordered. If the user orders more treatments or extend thetreatment allotted time; in step 282, the processor may remotely addmore treatments to the counter 185, and additional coolants and linersmay be sent to the user; or the allotted time may be extended.

In step 284, the processor may determine based on the remote access tothe counter 185 or whether the allotted time has passed, the processormay determine if the user is finished with the applicator 101, andrequest from the user whether the user would like to order moretreatment. In step 286, if the user is finished with the applicator,then the applicator may be returned to the provider. The provider maythen receive the returned applicator and recondition the applicator tothe proper working order and rent the applicator as part of the kit foranother user.

FIG. 16 shows a bottom view of an applicator 300 having a container 302with a base 303 divided into two pods 304 and 306. Each cooling pod mayhave a cooling plate 308 thermally coupled to two TECs 310 and 312underneath the cooling plate 308 represented as dotted lines. Each ofthe TECs 310 and 312 may be rated at about half of the cooling power asthe TEC 136 used in reference to the container in FIG. 5. For instance,the TEC 136 may be rated 12 A at 12V while each of the TECs 310 and 312may be rated at 6 A at 12V such that the two TECs 310 and 312 mayconsume about the same amount of power as the TEC 136. However, with thetwo TECs 310 and 312 having more thermal surface area contact with thecooling plate 308, the cooling may be more evenly distributed to thetargeted area of the skin to improve the thermal conductivity betweenthe cooling plate and the targeted area of the skin. Note that containermay be formed from a flexible material such that each pod may moveindependently with respect to the other to improve the thermalconductivity between the cooling plate and the targeted area of theskin.

FIG. 17 show that the base 303 may be divided into four cooling pods314, 316, 318, and 320 to allow each of the pods to move independentlyto better contour the surface of the skin. As such, it is within thescope of the invention to have one cooling pods or a plurality of podsin odd or even numbers. For instance, FIG. 18 shows a bottom view of anapplicator 400 having a base 402 with more than one cooling pods 402,such as three cooling pods 402, to cover a larger targeted area. Thebase 402 may be flexible to allow each of the cooling plates 404 to moveindependently.

FIG. 19 shows a perspective of an applicator 501 including a container502 having a rim 504 adapted to couple to a lid 506. The lid 506 mayhave a cover 508 adapted to release from the lid 506. The applicator 501may have a duct 510 to route the electrical cables having a plug adaptedto electrically couple to the power supply similarly shown in FIG. 1.The duct 510 may house a pump (not shown) to generate a vacuum pressurewithin a chamber 512 as discussed in more detail below. As discussed inreference to FIG. 2, the cover 508 may be removed to insert ice cubesinto the container 502 until the ice substantially fills up thecontainer 502, and then the coolant within the pouch 117 may be pouredinto the applicator 501 to substantially fill in the gap amongst the icecubes. The container 502 may be formed from a flexible non-porousmaterial such as rubber, or a rigid material, or transparent material,or any other material known to one skilled in the art configured to holdliquid there within. The container may be configured to hold from 60 ozto 140 oz of water; and in particular, from 80 oz to 120 oz of water,and in further particular about 100 oz of water. Accordingly, a coolingsystem 500 may be comprised of the applicator 501, the power supply 114,the pouch 117 fill with coolant, and the liner 160.

FIG. 20 shows the applicator 501 with the lid 506 removed showing theinterior space 514 of the container 502. The container 502 may have abase 516 with first and second side walls 518 and 520, respectively, andthird and fourth side walls 522 and 524, respectively, conjoining toform a top side 526. The top side 526 may have a first pipe 528 and asecond pipe 530. The side walls may form the chamber 512 underneath thebase 516. The first and second side walls 518 and 520 may each have oneor more openings 532 adapted to receive a TEC such that the cold sidefaces the chamber and hot side faces the interior space 514 of thecontainer 502 adapted to thermally couple to the radiator 130, asdiscussed above in reference to FIG. 8. As illustrated in FIG. 20, eachof the side walls 518 and 520 may have one or more TEC systems 538. EachTEC system 538 may include a TEC between a cooling plate (not shown) andthe radiator 130. In this embodiment, the applicator 501 may have twoTEC systems 538 on each of the side walls for a total of four TECsystems 538. Note that in FIG. 20, one of the TEC system 538 has beenremoved on the side wall 518 and side wall 520 to show the opening 532adapted to receive the TEC. The container 502 may also include atemperature sensor 539 to measure the temperature of the coolant, and asensor 541 to measure the coolant to determine if the coolant is anauthorized coolant or not.

FIG. 21 shows that the container 502 may include a pump 540 adapted toremove the air within the chamber 512 to generate vacuum pressure withinthe chamber 512. The pump 540 may have an inlet pipe 542 to receive airand an outlet pipe 544. The applicator may include a first tube 546coupling the inlet pipe 542 to the second pipe 530 to at least partiallyremove the air inside the chamber 512. The first tube 546 may be routedthrough a first hole 548, which may be sealed to prevent the coolantfrom leaking through the hole 548. The applicator may also include asecond tube 550 with one end coupled to the first pipe 528 to rout theelectrical wires (not shown) for the four TECs positioned along thefirst and second side walls 518 and 520, and temperature sensor wiresthrough a second hole 552 and out of the container 502. The electricaland temperature sensor wires may form the electrical cables to providepower to the TECs and to measure the temperature of the cooling plates.The applicator may also include a seal 554 with a lip 556 configured tocontour the surface area of the targeted area of the skin. The lip 556may have a semi-concave configuration to wrap around the round contourshape of the body. Depending on the contour of the body, the seal 554may be removed and replaced with another seal that better matches thecontour of the user's targeted area of the skin.

FIG. 22 show a bottom perspective view of the applicator 501 to show thechamber 512 underneath the base 516 of the container 502. Within thechamber 512, each of the first and second side walls 518 and 520 mayhave a cooling plate 560 thermally coupled to the two TECs within theopenings 532, as discussed in more detail below. The cooling plate 560may be sealed to the side wall within the chamber to substantiallyprevent coolant and/or liquid within the container 502 from leaking intothe chamber 512 due to the vacuum pressure within the chamber. The seal554 may have a base 562 that is releasably coupled to the base 516 ofthe container 502. The seal may be formed from a flexible material suchas rubber to form an air tight seal between the seal 552 and thetargeted area of the skin.

FIG. 23 show a cross-sectional view of the applicator 501 of FIG. 19along the line 23. The rim 504 of the container 502 may be adapted tocouple to the lid 506. The base 516 of the container 502 may have thecamber 512 in the form of an inverted “U” shape defined by the first andsecond side walls 518 and 520 adapted to thermally couple to one or moreTEC systems 538. The cooling system may include a TEC 136 between theradiator 130 and the cooling plate 560. TEC 136 may be thermally coupledto the radiator and the cooling plate with thermal paste with the hotside of the TEC juxtaposed to the radiator 130 and the cold side of theTEC juxtaposed to the cooling plate. The radiators and the coolingplates may be sealed to their respective side walls to prevent coolantfrom leaking into the chamber 512 due to the vacuum pressure. The base516 of the container 502 may be adapted to releasably couple to the seal554 to minimize the resistance of the targeted area of the skin beingsucked into the chamber 512.

The pump may be draw air out of the chamber 512 through the first pipe528 to create at least a partial vacuum pressure within the chamber 512to draw the targeted area of the skin 570 into the chamber 512. This mayminimize the gap between the skin and the two adjacent cooling plates560 to efficiently conduct heat away from the targeted area of the skinthrough the cooling plates as indicated by the direction arrows 572 and574. This allows the targeted area of the skin having the three layers164, 166, and 168 to be folded such that the two outer cooling plates560 may draw heat away from the three layers 164, 166, and 168 from bothsides as indicated by the direction arrows 572 and 574, therebyimproving the efficiency of crystallizing the fatty cells 168 locatedwithin the folded area of the skin. Each of the cooling plates 560 maybe thermally coupled to a temperature sensor 561 held by a bracket 563to measure the temperature of their respective cooling plates 560. Thewires 565 for the TECs 136 and the temperature sensors 561 may be routedwithin the chamber 512 and through the first pipe 528 to provide powerto the TECs and measure the temperatures.

FIG. 24 a cross-sectional view of the applicator 501 of FIG. 19 alongthe line 24. In this embodiment, the one cooling plate 560 may bethermally coupled to two TECs 136, however, it is within the scope ofthe invention to have a dedicated cooling plate for each of the TECs. Itis also within the scope of the invention to have one elongated radiatorthermally coupled to the two TECs along each of the side walls 518 and520, instead of using a dedicated radiator for each of the TECs. Theelectrical wires 565 for the TECs 136 and the temperature sensors 563may be routed within the chamber 512 and exit through the first pipe 528through the tube 550 and to the power supply. The second pipe 530 may becoupled to the tube to draw air out of the chamber 512. The temperaturesensors 561 may be held between the brackets 563 and the correspondingcooling plates 560 to measure the temperature of the cooling plates.

FIG. 25 shows a controller block diagram 584 adapted to operate theapplicator 501, which is similar to the controller 180 shown in FIG. 10,with the difference being that the processor 182 controls the powersupply 114 to provide power to the pump 540. The processor 182 maycontrol the power supply 114 to adjust the voltage provide to the pump540 to vary the speed of the pump 540, thereby adjusting the vacuumpressure within the chamber 512. The processor 182 may be communicablycoupled to the power supply 114, the memory 184, one or more TECs 136,temperature sensors 561 to measure the temperature of the correspondingTECs 136 or the temperatures of the cooling plates 560, the temperaturesensor 539 to measure the temperature of the coolant, and the sensor 541to measure the coolant to determine if the coolant is an authenticatecoolant or not. The processor 184 may be communicably coupled to thecounter 185 configured to keep track a number of times the applicator501 has been used.

FIG. 26 shows a flow chart 590 directed to monitoring the temperature ofthe coolant to cool the cooling plates within a predetermined range ofcooling temperature for a predetermined period of time for theapplicator 501. The flow chart 590 may be similar to the flow chart 220shown in FIG. 13 but with the addition of step 592 to provide power tothe pump 540 to generate a desired vacuum pressure within the chamber512 to draw the targeted area of the skin 570 into the chamber. Theremaining steps may be substantially similar to the steps discussed inthe flow chart 220. Note that other flow charts 186, 206, 240, and 270may apply to the applicator 501, although steps in those flow chartshave not been discussed relating to the applicator 501.

Testing Sample Vacuum Applicator:

For testing purposes, an applicator similar to the drawings shown inFIGS. 19 through and 24, was constructed with a container configured tohold about 112 oz of water. Four TEC1-12706 rated at 12V and 6 amp wereused with each of the TECs having a square dimension of 40 mm (width)×40mm (height)×3.2 mm (depth). The hot side of each of the TEC wasthermally coupled to a radiator which is similar to the radiator 130described above in FIG. 8. The cold side of each of the TEC wasthermally coupled to the cooling plate generally having an isoscelestrapezoid shape with the W (width) of about 5.31″ (135 mm) and H(height) of about 2.95″ (75 mm) as shown in FIG. 24. Both the radiators130 and the cooling plates 560 are made of aluminum material. Thermalpaste were used to ensure good thermal conductivity amongst theradiators 130, TECs, and the cooling plates 560. The widths of thecooling plates and the radiators are both wider than the square openingto substantially seal around the square opening. Screws were used tocouple the radiators and the cooling plates together to ensure that theradiator and the cooling plate remained in good thermal contact. Sealantwas applied over the screws, and between the radiator 130 and the sidewalls 518 and 520 of the container, and between the cooling plates 560and the opposite sides of the side walls 518 and 520 to substantiallyprevent the coolant and/or liquid from leaking out of the container.

FIG. 27 shows a flow chart 594 relating the cooling procedure utilizingthe applicator 501. The flow chart 594 may be similar to the flow chart186 of FIG. 11, except that the step 188 may be skipped and step 596 hasbeen added to provide power to the pump to generate a desired vacuumpressure within the chamber, as discussed in more detail. For thetesting purposes, in step 190, about 1,300 grams of ice cubes (solidcoolant) were inserted into the applicator 501. In step 192, theapplicator 501 was then filled with about 1,600 grams of fluid coolant.The fluid coolant used in this test was formulated by using a blender tocrush about 1000 grams of ice cubes with about 500 grams of chilledwater at about 4° C., and about 100 grams of rubbing alcohol at about−11° C. The rubbing alcohol allowed the coolant to be more fluid so thatthe coolant could be poured into the container more easily. Thecombination of about 2900 grams or about 102 oz of ice cubes (solidcoolant) and fluid coolant measured about −2° C. inside the applicator.

In step 194, a protective liner was placed over the right flank or thetargeted area. In step 196, the applicator was placed over the targetedarea and one thermocouples was placed between each of the cooling platesand the protective liner to measure the temperature of the both coolingplates.

In step 596, power to the pump was provided to generate a desired vacuumpressure within the chamber. The pump used for this test was fromShenzhen Yanhua Faith Technology co., ltd., a model numberZX512-903-4000 with the voltage rating of DC 9V-12V, vacuum capacity of80 Kpa, nominal flow of 15 L/min, nominal voltage of 12V, and the powerrating of 10 Watt. A variable power supply was connected to the pump andthe voltage was set at about 7.0V to supply power to the pump. Thiscaused vacuum pressure to be generated within the chamber therebycausing the targeted area of the skin to be drawn about a half way intothe chamber.

In step 200, power was provided to the four TECs to cool the targetedarea of the skin. Power can be provided by connecting the electricallycables to a PWM power supply to supply DC current to the four TECs. Thepower supply was then turned ON and OFF to further lower the temperatureof the cooling plates within a temperature range of between −2° C. and−6° C. In other words, the power supply was turned ON when thetemperature rose to −2° C. and it was turn OFF again when thetemperature dropped to −6° C., and vice versa. The procedure lastedabout 60 minutes, and at which time the power to the pump and the fourTECs were turned OFF. After the procedure, some ice cubes still remainedwithin the applicator.

In step 202, the applicator 501 was removed from the targeted area ofthe skin. Shortly thereafter, the temperature of the coolant wasmeasured, and it was about 2° C. Note that after the cooling treatment,the most of the ice cubes or solid coolant have melted and mixed withthe fluid coolant. The targeted area of the skin was examined, and itwas noticed that some portion of the targeted area of the skin was redand protruded out somewhat like a harden butter stick, indicating thatsome portion of the subcutaneous fat cells were harden or crystalized.And in step 204, the targeted area of the skin was massaged to softenthe hardened area of skin, and after the massage, the protruding area ofthe skin subsided.

After about two weeks of the cooling treatment as noted above inreference to the flow chart 594, the same targeted area of the skin, theright flank, was treated again similar to the treatment outlined in theflow chart 594. In other words, the same targeted area of the rightflank was treated twice within two weeks, but the left flank wasuntreated to measure the difference between the treated and untreatedareas of the body due to the cooling treatment outlined above. Aftermore than 10 weeks after the second treatment on the right flank, themeasurements were taken around the left and right waist circumferencesfrom the belly button to the center back. The total waist circumferencewas measured to be 36.0 inches. The right side of the waistcircumference, the right flank area which was treated twice, measured17.5 inches from the center of the belly button to the center of theback. Conversely, the left side of the waist circumference, the leftflank area which was untreated, measured 18.5 inches from the center ofthe belly button to the same center of the back so the combination ofthe right and left circumference measurements were same as the totalwaist circumference measurement of 36.0 inches. Beyond the tapemeasurements, the reduction of the body fat on the right flank wasnoticeable compared to the left flank. As such, the cooling treatmentsto the right flank appears to have reduced the fat cells in the treatedarea resulting in about 1.0″ reduction of waist circumference. Treatingone side of the flank was done to eliminate the possibility that otherfactors may have reduced the fat cells such as either exercise or diet.Accordingly, treating both the left and right flanks may reduce thewaist circumference by about 2.0 inches.

In the test conducted above, the combined initial temperature of thesolid coolant and the fluid coolant in the applicator was about −2° C.With a colder combined coolant temperature in the applicator, such asbelow −10° C., the four TECs may cool the cooling plates to about −10°C. for about 50 minutes, at which point in time most if not all of theice cubes in the applicator may be melted; at which time, the coolingplates may be cooled to about −5° C. for another 10 minutes. As such,depending on the duration of the cooling treatment and/or if coldertemperature is desired at the cooling plates, colder fluid coolant maybe utilized.

FIG. 28 shows an applicator 601 similar to the applicator 501 describedin FIGS. 19-24 but without the cooling plate and the TEC. The applicator601 may have a container 602 with the side walls 604 and 606 adapted tocouple with radiators 608 and 610, respectively. Coolant, a mixture ofsolid and fluid coolants, may be inserted into the container 602 and thelid 612 may be used to seal the coolant inside the container. Theapplicator 601 filled with the coolant may be placed inside a freezerfor a period of time to freeze the coolant and the applicator 601. Thecoolant may be selected such that after the applicator has been in thefreezer, the coolant may remain fluid to extract the heat from thetargeted area of the skin and substantially maintain the temperaturealong the base 614 and 616 of the radiators 608 and 610 at a desiredranged of temperature for a desired period of time.

FIG. 29 shows a cross-sectional view of a cooling system 700 includingan applicator 701 having one or more TECs 704 and 706 coupled to aninner liner 708 dividing first and second coolants 710 and 712. Theapplicator 701 may be formed from flexible material so that it canconform to the contour of the targeted area of the skin. The TECs 706may be between a first radiator 714 and a second radiator 716. Each ofthe TECs 704 and 706 may have wires 718 and 720, respectively,protruding from the applicator 701 to supply power to the TECs. Thewires may be combined to form a cable 722 having a plug 724 adapted toplug into a power supply 726 such as a DC battery so that the coolingsystem 700 may be portable. The cooling system 700 may also include oneor more temperature sensors 728 adapted to measure the temperaturebetween the second compounds 712 and the targeted area of the skin. Theapplicator 701 may have a first side 730 adapted to make contact withthe targeted area of the skin and maintain the temperature within apredetermined range of temperatures by adjusting the power supplied tothe TECs 704 and 706.

The applicator 701 may be placed inside a freezer to allow the coolants710 and 712 to reach a desired cooling temperatures such that thecoolants 710 may be solid or fluid. The cooling capacity of the firstand second coolants 710 and 712 may be same or different depending onthe application. For instance, the coolant 712 may have a lower freezingpoint compared to the coolant 710, and vice versa. After the applicator701 has been chilled, the applicator may be used for a variety oflocalized cryotherapy known to one skilled in the art such as for backpains, sports injuries to the knee, shoulder, ankle, elbow, and for footinjuries and for gout. The applicator 701 may include an elastic strap732 with both distal ends 734 adapted to couple to each other such asthrough Velcro. Depending on the application, an antifreeze liner 160may be placed over the targeted area of the skin to protect the skin, ifthe desired cooling temperature on the targeted area is too low suchthat it may damage the skin. Once the pouch is placed over the targetedarea of the body, the temperature sensors 728 may monitor thetemperature along the first side 730. If the temperature along the firstside 730 is above a predetermined upper limit of cooling temperature,the power to the TECs 704 and 706 may be provided such that the coldside of the TECs cools the second radiators 716 by utilizing the firstcoolants 710 as the heat skin to absorb the heat from the first radiator714.

Conversely, if the temperature sensors 728 indicate that the temperaturealong the first side 730 is below the predetermined cooling lower limittemperature, then the power to the TECs may be turned OFF or thepolarity of the voltage may be reversed so that the first radiator 714cools and the second radiator 716 heats. This way, by utilizing thefirst coolant as the heat sink, the temperature of the second coolant712 and the first side 730 may be substantially maintained within apredetermined range of temperatures and for a longer period of timecompared to traditional icepacks.

FIG. 30 show a cooling system 750 with a plurality of applicators 701tethered together in a series with a strap 732. The cooling system 750may be used to wrap around a larger torso area such as around theabdomen to treat the belly, and both left and right flanks at the sametime.

While various embodiments of the invention have been described, it willbe apparent to those of ordinary skill in the art that many moreembodiments and implementations are possible within the scope of thisinvention. For instance, the cooling plates may formed utilizing 3Dprinting technology to customize certain features of the body such aschin and foot to better fit such body parts to improve the thermalconductivity between the customized cooling plate and the body parts.Moreover, various features and functionalities described in thisapplication and Figures may be combined individually and/or plurality offeatures and functionalities with others. Accordingly, the invention isnot to be restricted except in light of the attached claims and theirequivalents.

What is claimed is:
 1. A cooling system for extracting heat away from atargeted area of the body, the cooling system comprising: athermoelectric cooler (TEC) having a hot side and a cold side; and anapplicator having a container coupled to the TEC, and the container issized to hold a predetermined amount of coolant within the containerchilled below 0° C. such that, when the container is filled with thepredetermined amount of coolant and the TEC is powered, thepredetermined amount of coolant contained within the container extractsheat away from the hot side of the TEC so that the cold side of the TECcan substantially maintain a temperature within a predetermined cooltemperature range below 0° C. for a predetermined period of time of atleast 30 minutes without re-cooling the predetermined amount of coolantcontained within the container to extract heat away from the targetedarea of the body in order to crystalize at least a portion of fat cellsunderneath the targeted area of the skin without damaging the skin;wherein the cooling system does not include a pump that circulatescoolant to and from the applicator.
 2. The cooling system according toclaim 1, where the container has a divider that divides the containerinto a first section and a second section, the TEC coupled to thedivider, the first section containing the predetermined amount ofcoolant to extract heat away from the hot side of the TEC, and thesecond section containing a second predetermined amount of coolant suchthat the cold side of the TEC can extract heat away from the secondpredetermined amount of coolant.
 3. The cooling system according toclaim 1, including a radiator thermally coupled to the hot side of theTEC such that, when the container is filled with the predeterminedamount of coolant, the first radiator is between the predeterminedamount of coolant and the hot side of the TEC.
 4. The cooling systemaccording to claim 1, including a pump, and the container has a chambercoupled to the pump such that when power is provided to the pump, apredetermined vacuum pressure is generated within the chamber to drawthe targeted area of the body into the chamber to allow the cold side ofthe TEC to extract heat away from the targeted area of the body.
 5. Thecooling system according to claim 1, where the applicator has a chamberconfigured to draw the targeted area of the skin into the chamber, thechamber having first and second side walls, where each of the first andsecond side walls has at least one TEC adapted to draw heat away fromthe targeted area of the skin.
 6. The cooling system according to claim1, including a controller communicably coupled to the TEC to control thepower provided to the TEC to maintain the temperature within thepredetermined cool temperature range for the predetermined period oftime.
 7. The cooling system according to claim 1, including a counterthat is programmable with a predetermined number of authorized treatmentcycles, the counter configured to keep track of the number of treatmentcycles performed by the applicator and deactivating the applicator afterthe predetermined number of authorized treatment cycles have beenperformed.
 8. The cooling system according to claim 1, where thecontainer is formed from a flexible material having a base, the basehousing the TEC such that the hot side is thermally coupled to aradiator that can exchange heat with the predetermined amount of coolantwithin the container when the container is filled with the predeterminedamount of coolant, and the cold side of the TEC is thermally coupled toa cooling plate.
 9. The cooling system according to claim 1, where thepredetermined amount of coolant includes a first portion of solidcoolant and a second portion of fluid coolant, and the fluid coolantsubstantially remains fluid when chilled below −5° C.
 10. The coolingsystem according to claim 1, where the predetermined amount of coolantincludes a first portion of solid coolant and a second portion of fluidcoolant, the first portion of the solid coolant is ice cubes, and thesecond portion of the fluid coolant substantially remains fluid whenchilled below −10° C.
 11. The cooling system according to claim 1, wherethe predetermined amount of coolant includes fluid coolant thatsubstantially remains fluid when chilled below −10° C.
 12. The coolingsystem according to claim 1, where the predetermined amount of coolantis at least 60 oz and remains fluid when chilled below −10° C.
 13. Thecooling system according to claim 1, including a lid adapted to open andenclose the container such that when the lid is open, the predeterminedamount of coolant can be poured into the container.
 14. The coolingsystem according to claim 1, where the container is configured to holdat least 40 oz of water.
 15. The cooling system according to claim 1,where the predetermined amount of coolant is at least 40 oz that can bechilled below 0° C. so that, when the TEC is powered, the temperature ofthe cold side of the TEC can be maintained below 0° C. for at least 30minutes.